I cover cardiology news for CardioExchange, a social media website for cardiologists published by the New England Journal of Medicine. I was the editor of TheHeart.Org from its inception in 1999 until December 2008. Following the purchase of TheHeart.Org by WebMD in 2005, I became the editorial director of WebMD professional news, encompassing TheHeart.Org and Medscape Medical News. Prior to joining TheHeart.Org, I was a freelance medical journalist and wrote for a wide variety of medical and computer publications. In 1994-1995 I was a Knight Science Journalism Fellow at MIT. I have a PhD in English from SUNY Buffalo, and I drove a taxicab in New York City before embarking on a career in medical journalism. You can follow me on Twitter at: @cardiobrief.

Oops, She Did It Again! FDA Disinvites Another Advisor

Today an FDA advisory panel will meet to review the safety of oral contraceptives that contain drospirenone. One person who will not be voting on the panel is Sidney Wolfe, the well known consumer advocate and pharma critic. Wolfe was originally listed as a panel member, but then, only 2 days before the meeting, he was removed from the panel by none other than Janet Woodcock, the imperious director of the FDA’s Center for Drug Evaluation and Research (CDER). Her reason: Wolfe had an intellectual conflict of interest because he had already said the drug should not be used in his Worst Pills newsletter and website.

After some back and forth, as detailed here, Wolfe will end up taking part in the proceedings, but he will not be able to vote. There are a lot of different issues involved here, many quite complex. But there’s one aspect of the issue that strikes me as quite simple: Woodcock and the FDA had absolutely no justification for removing Wolfe from the panel so shortly before the scheduled meeting. Any concerns about Wolfe should have been thoroughly reviewed and discussed long before, when the FDA first began to assemble the panel. Wolfe is an extremely public figure (some might argue too public), so it would not have been hard to determine if his previous statements made him ineligible to participate.

A similar event occurred two and a half years ago when Sanjay Kaul was removed without explanation from the prasugrel (Efient, Lilly) advisory panel (as recounted here, here, here, and here), provoking considerable controversy and two congressional investigations.

It seems clear to me that once a panel has been chosen and the members invited, only an extraordinary event or revelation should prompt a last minute change. These last minute shenanigans in the Kaul and Wolfe cases raise the suspicion that people outside the FDA (any guesses?) complained about the presence of panel members they disliked and used their connections to exert influence.

This suspicion appears to be justified. I asked the FDA to explain what happened in the Wolfe case:

…the FDA recently became aware of and confirmed that Public Citizen lists Yasmin, Yaz, and other drosperinone-containing products on its “Do Not Use” list and also recommended — in a Public Citizen newsletter “Worst Pills/Best Pills” – that patients not use drosperinone-containing products “due to the increased risks of blood clots.” Dr. Wolfe serves as editor of the “Worst Pills/Best Pills” newsletter. Dr. Wolfe did not disclose this information to the FDA and was therefore previously cleared to participate in the December 8th meeting.

This is the same sequence of events that took place when Kaul was removed from the prasugrel hearing. As eventually became clear, Kaul was disinvited from the meeting after the sponsor (Lilly) complained to FDA officials that Kaul had been critical of prasugrel in the past. So, in essence, Kaul and Wolfe were kicked off an expert panel for being, well, experts. Hmmm.

Ed Silverman and Merrill Goozner have contributed some very thoughtful additions to the conflict of issue discussion. I’d like to ask just one question: do we really want to choose advisory committee panelists who have never expressed opinions about the topics they are reviewing? Are we reaching the point where potential FDA panelists will be required, like Supreme Court nominees, to have avoided any discussion of all important issues at every point in the past?

Post Your Comment

Post Your Reply

Forbes writers have the ability to call out member comments they find particularly interesting. Called-out comments are highlighted across the Forbes network. You'll be notified if your comment is called out.